Trial Outcomes & Findings for A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis (NCT NCT00424294)

NCT ID: NCT00424294

Last Updated: 2014-09-25

Results Overview

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2014-09-25

Participant Flow

Participant milestones

Measure	Placebo and Celecoxib Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Overall Study STARTED	36	34
Overall Study Treated	35	34
Overall Study COMPLETED	28	19
Overall Study NOT COMPLETED	8	15

Reasons for withdrawal

Measure	Placebo and Celecoxib Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Overall Study Adverse Event	4	10
Overall Study Lack of Efficacy	2	1
Overall Study Withdrawal by Subject	1	2
Overall Study Other	0	2
Overall Study Randomized but not Treated	1	0

Baseline Characteristics

A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.	Total n=69 Participants Total of all reporting groups
Age, Continuous	54.1 years STANDARD_DEVIATION 11.6 • n=5 Participants	57.7 years STANDARD_DEVIATION 12.7 • n=7 Participants	55.9 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	27 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using last observation carried forward (LOCF) method.

ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12	31.43 percentage of participants	35.29 percentage of participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.

ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 Week 1	31.43 percentage of participants	23.53 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 Week 2	28.57 percentage of participants	35.29 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 Week 4	28.57 percentage of participants	41.18 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 Week 8	25.71 percentage of participants	38.24 percentage of participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.

ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 1	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 2	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 4	8.57 percentage of participants	2.94 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 8	5.71 percentage of participants	11.76 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 12	8.57 percentage of participants	14.71 percentage of participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.

ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 1	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 2	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 4	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 8	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 12	2.86 percentage of participants	2.94 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.

Participants were assessed for tender/painful joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12 Baseline (n=35, 34)	15.54 tender/painful joints Standard Deviation 5.55	13.74 tender/painful joints Standard Deviation 7.15
Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12 Change at Week 1 (n=33, 31)	-4.45 tender/painful joints Standard Deviation 5.15	-4.68 tender/painful joints Standard Deviation 6.29
Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12 Change at Week 2 (n=34, 31)	-3.82 tender/painful joints Standard Deviation 6.24	-6.13 tender/painful joints Standard Deviation 6.15
Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12 Change at Week 4 (n=31, 25)	-5.68 tender/painful joints Standard Deviation 6.48	-5.04 tender/painful joints Standard Deviation 6.09
Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12 Change at Week 8 (n=33, 24)	-5.15 tender/painful joints Standard Deviation 6.46	-6.00 tender/painful joints Standard Deviation 7.68
Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12 Change at Week 12 (n=30, 21)	-5.67 tender/painful joints Standard Deviation 5.86	-5.95 tender/painful joints Standard Deviation 9.45

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.

Participants were assessed for swollen joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12 Baseline (n=35, 34)	11.49 swollen joints Standard Deviation 4.85	12.00 swollen joints Standard Deviation 5.75
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12 Change at Week 1 (n=33, 31)	-3.18 swollen joints Standard Deviation 4.23	-4.35 swollen joints Standard Deviation 4.41
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12 Change at Week 2 (n=34, 31)	-2.74 swollen joints Standard Deviation 5.59	-5.97 swollen joints Standard Deviation 5.27
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12 Change at Week 4 (n=31, 25)	-3.45 swollen joints Standard Deviation 6.20	-6.32 swollen joints Standard Deviation 4.71
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12 Change at Week 8 (n=33, 24)	-2.79 swollen joints Standard Deviation 6.38	-6.71 swollen joints Standard Deviation 5.44
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12 Change at Week 12 (n=30, 21)	-3.80 swollen joints Standard Deviation 6.70	-6.38 swollen joints Standard Deviation 6.10

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.

Patient's assessment of arthritis pain was assessed using a 100 millimeter (mm) visual analogue scale (VAS) with range: 0 = no pain to 100 = worst possible pain.

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12 Change at Week 8 (n=33, 24)	-14.06 mm Standard Deviation 24.82	-12.04 mm Standard Deviation 29.37
Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12 Baseline (n=35, 34)	50.94 mm Standard Deviation 23.36	54.74 mm Standard Deviation 22.25
Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12 Change at Week 1 (n=33, 30)	-13.27 mm Standard Deviation 20.21	-11.33 mm Standard Deviation 15.97
Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12 Change at Week 2 (n=34, 32)	-9.53 mm Standard Deviation 23.98	-9.50 mm Standard Deviation 23.65
Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12 Change at Week 4 (n=31, 25)	-8.16 mm Standard Deviation 23.62	-14.12 mm Standard Deviation 24.97
Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12 Change at Week 12 (n=30, 21)	-11.50 mm Standard Deviation 22.90	-21.43 mm Standard Deviation 35.24

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.

Patient's global assessment of arthritic condition assessed all the ways participants' illness and health conditions affect them at the time of assessment. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 Baseline (n=35, 34)	3.14 units on a scale Standard Deviation 0.88	3.24 units on a scale Standard Deviation 0.89
Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 Change at Week 1 (n=33, 31)	-0.58 units on a scale Standard Deviation 0.83	-0.48 units on a scale Standard Deviation 0.89
Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 Change at Week 2 (n=34, 31)	-0.38 units on a scale Standard Deviation 0.92	-0.61 units on a scale Standard Deviation 0.95
Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 Change at Week 4 (n=31, 25)	-0.39 units on a scale Standard Deviation 0.95	-0.68 units on a scale Standard Deviation 0.95
Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 Change at Week 8 (n=33, 24)	-0.58 units on a scale Standard Deviation 0.90	-0.46 units on a scale Standard Deviation 1.02
Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 Change at Week 12 (n=30, 21)	-0.40 units on a scale Standard Deviation 1.22	-0.57 units on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.

Investigator assessed overall appearance of arthritis at the time of the visit. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 Baseline (n=35, 34)	3.37 units on a scale Standard Deviation 0.49	3.32 units on a scale Standard Deviation 0.59
Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 Change at Week 1 (n=33, 31)	-0.76 units on a scale Standard Deviation 0.61	-0.58 units on a scale Standard Deviation 0.67
Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 Change at Week 2 (n=34, 31)	-0.74 units on a scale Standard Deviation 0.83	-0.58 units on a scale Standard Deviation 0.76
Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 Change at Week 4 (n=31, 25)	-0.71 units on a scale Standard Deviation 0.94	-0.60 units on a scale Standard Deviation 0.71
Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 Change at Week 8 (n=33, 24)	-0.67 units on a scale Standard Deviation 1.05	-0.71 units on a scale Standard Deviation 0.69
Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 Change at Week 12 (n=30, 21)	-0.67 units on a scale Standard Deviation 0.99	-0.67 units on a scale Standard Deviation 1.20

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.

Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12 Baseline (n=34, 34)	1.65 units on a scale Standard Deviation 0.54	1.65 units on a scale Standard Deviation 0.65
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12 Change at Week 1 (n=32, 30)	0.34 units on a scale Standard Deviation 0.43	-0.18 units on a scale Standard Deviation 0.34
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12 Change at Week 2 (n=31, 29)	-0.18 units on a scale Standard Deviation 0.54	-0.24 units on a scale Standard Deviation 0.38
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12 Change at Week 4 (n=30, 25)	-0.34 units on a scale Standard Deviation 0.56	-0.29 units on a scale Standard Deviation 0.46
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12 Change at Week 8 (n=32, 24)	-0.38 units on a scale Standard Deviation 0.67	-0.30 units on a scale Standard Deviation 0.61
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12 Change at Week 12 (n=29, 20)	-0.38 units on a scale Standard Deviation 0.59	-0.44 units on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12 Baseline (n=34, 34)	0.93 milligram per deciliter (mg/dL) Standard Deviation 0.69	1.36 milligram per deciliter (mg/dL) Standard Deviation 1.35
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12 Change at Week 1 (n=32, 31)	-0.06 milligram per deciliter (mg/dL) Standard Deviation 0.75	0.15 milligram per deciliter (mg/dL) Standard Deviation 1.33
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12 Change at Week 2 (n=32, 31)	0.08 milligram per deciliter (mg/dL) Standard Deviation 0.66	0.61 milligram per deciliter (mg/dL) Standard Deviation 2.05
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12 Change at Week 4 (n=29, 25)	0.67 milligram per deciliter (mg/dL) Standard Deviation 3.78	0.16 milligram per deciliter (mg/dL) Standard Deviation 1.35
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12 Change at Week 8 (n=32, 24)	0.15 milligram per deciliter (mg/dL) Standard Deviation 0.75	0.41 milligram per deciliter (mg/dL) Standard Deviation 1.29
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12 Change at Week 12 (n=29, 21)	0.60 milligram per deciliter (mg/dL) Standard Deviation 3.47	0.03 milligram per deciliter (mg/dL) Standard Deviation 0.78

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.

DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP. It was calculated as DAS28-3 (CRP) = 1.15 + 1.10 * ([0.56 * square root of TJC] + [0.28 * square root of SJC] + [0.36 * natural logarithm of {CRP+1}]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12 Baseline (n=34, 34)	4.78 units on a scale Standard Deviation 0.56	4.68 units on a scale Standard Deviation 0.84
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12 Change at Week 1 (n=32, 31)	-0.65 units on a scale Standard Deviation 0.66	-0.71 units on a scale Standard Deviation 0.81
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12 Change at Week 2 (n=32, 31)	-0.56 units on a scale Standard Deviation 0.87	-0.86 units on a scale Standard Deviation 0.72
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12 Change at Week 4 (n=29, 25)	-0.82 units on a scale Standard Deviation 1.04	-0.83 units on a scale Standard Deviation 0.77
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12 Change at Week 8 (n=32, 24)	-0.84 units on a scale Standard Deviation 0.96	-1.04 units on a scale Standard Deviation 1.05
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12 Change at Week 12 (n=29, 21)	-0.98 units on a scale Standard Deviation 1.07	-1.19 units on a scale Standard Deviation 1.40

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.

Duration of morning stiffness was defined as the time elapsed between the time participant woke up and was able to resume normal activities without stiffness in hours (duration was recorded in hours to the nearest quarter. For those participants with unrelenting stiffness, duration was recorded as 24 hours).

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12 Change at Week 12 (n=30, 21)	1.05 hour Standard Deviation 7.61	-1.65 hour Standard Deviation 5.01
Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12 Baseline (n=35, 34)	2.83 hour Standard Deviation 3.68	3.22 hour Standard Deviation 4.34
Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12 Change at Week 1 (n=33, 31)	-0.11 hour Standard Deviation 1.83	-0.61 hour Standard Deviation 1.50
Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12 Change at Week 2 (n=34, 31)	0.03 hour Standard Deviation 2.16	-1.34 hour Standard Deviation 4.21
Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12 Change at Week 4 (n=31, 25)	-0.76 hour Standard Deviation 1.65	-1.51 hour Standard Deviation 4.53
Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12 Change at Week 8 (n=33, 24)	0.34 hour Standard Deviation 4.16	-1.03 hour Standard Deviation 5.09

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Number of Participants Who Withdrew From Study Due to Lack of Efficacy	2 participants	1 participants

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: Median time and corresponding confidence interval (CI) were not estimable because only less than half of the participants withdrew from study due to lack of efficacy and hence, were insufficient for the analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Week 13

Population: Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.

Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Number of Participants With Clinical Laboratory Abnormalities	15 participants	14 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after last dose

Population: Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	29 participants	31 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	1 participants	2 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after last dose

Population: Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Number of Adverse Events by Severity Mild	40 adverse events	41 adverse events
Number of Adverse Events by Severity Moderate	26 adverse events	25 adverse events
Number of Adverse Events by Severity Severe	0 adverse events	5 adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91

Population: Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, "n" signifies those participants who were evaluable at specified time point for each arm, respectively.

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated in sitting position.

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Baseline: SBP (n=35, 34)	123.7 millimeter of mercury (mmHg) Standard Deviation 12.33	124.6 millimeter of mercury (mmHg) Standard Deviation 14.97
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 7: SBP (n=33, 30)	-0.2 millimeter of mercury (mmHg) Standard Deviation 12.46	0.5 millimeter of mercury (mmHg) Standard Deviation 12.91
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 14: SBP (n=1, 5)	5.0 millimeter of mercury (mmHg) Standard Deviation NA Standard Deviation (SD) was not calculable as only 1 participant was evaluable at this time point.	3.2 millimeter of mercury (mmHg) Standard Deviation 4.15
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 21: SBP (n=0, 1)	NA millimeter of mercury (mmHg) Standard Deviation NA Data was not analyzed as there was no participant evaluable for this arm group at the specified time point.	0.0 millimeter of mercury (mmHg) Standard Deviation NA SD was not calculable as only 1 participant was evaluable at this time point.
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 28: SBP (n=1, 2)	18.0 millimeter of mercury (mmHg) Standard Deviation NA SD was not calculable as only 1 participant was evaluable at this time point.	0.0 millimeter of mercury (mmHg) Standard Deviation 0.0
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 42: SBP (n=4, 2)	3.3 millimeter of mercury (mmHg) Standard Deviation 4.57	0.0 millimeter of mercury (mmHg) Standard Deviation 28.28
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 56: SBP (n=0, 3)	NA millimeter of mercury (mmHg) Standard Deviation NA Data was not analyzed as there was no participant evaluable for this arm group at the specified time point.	-2.0 millimeter of mercury (mmHg) Standard Deviation 8.00
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 84: SBP (n=27, 17)	4.7 millimeter of mercury (mmHg) Standard Deviation 13.44	6.8 millimeter of mercury (mmHg) Standard Deviation 15.58
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 91: SBP (n=3, 3)	3.3 millimeter of mercury (mmHg) Standard Deviation 13.65	-15.7 millimeter of mercury (mmHg) Standard Deviation 12.58
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Baseline: DBP (n=35, 34)	77.9 millimeter of mercury (mmHg) Standard Deviation 8.03	75.8 millimeter of mercury (mmHg) Standard Deviation 10.81
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 7: DBP (n=33, 30)	-1.3 millimeter of mercury (mmHg) Standard Deviation 8.32	1.4 millimeter of mercury (mmHg) Standard Deviation 10.57
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 14: DBP (n=1, 5)	-1.0 millimeter of mercury (mmHg) Standard Deviation NA SD was not calculable as only 1 participant was evaluable at this time point.	1.2 millimeter of mercury (mmHg) Standard Deviation 7.16
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 21: DBP (n=0, 1)	NA millimeter of mercury (mmHg) Standard Deviation NA Data was not analyzed as there was no participant evaluable for this arm group at the specified time point.	16.0 millimeter of mercury (mmHg) Standard Deviation NA SD was not calculable as only 1 participant was evaluable at this time point.
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 28: DBP (n=1, 2)	-4.0 millimeter of mercury (mmHg) Standard Deviation NA SD was not calculable as only 1 participant was evaluable at this time point.	8.0 millimeter of mercury (mmHg) Standard Deviation 16.97
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 42: DBP (n=4, 2)	-1.8 millimeter of mercury (mmHg) Standard Deviation 7.76	-2.0 millimeter of mercury (mmHg) Standard Deviation 11.31
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 56: DBP (n=0, 3)	NA millimeter of mercury (mmHg) Standard Deviation NA Data was not analyzed as there was no participant evaluable for this arm group at the specified time point.	-4.0 millimeter of mercury (mmHg) Standard Deviation 7.21
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 84: DBP (n=27, 17)	1.4 millimeter of mercury (mmHg) Standard Deviation 7.77	-0.5 millimeter of mercury (mmHg) Standard Deviation 12.21
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 91: DBP (n=3, 3)	2.7 millimeter of mercury (mmHg) Standard Deviation 6.43	-5.3 millimeter of mercury (mmHg) Standard Deviation 4.62

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91

Population: Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, "n" signifies those participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91 Baseline (n=35, 34)	74.3 beats per minute Standard Deviation 7.62	74.5 beats per minute Standard Deviation 10.62
Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 7 (n=33, 30)	-1.0 beats per minute Standard Deviation 10.00	2.2 beats per minute Standard Deviation 9.70
Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 14 (n=5, 1)	-3.0 beats per minute Standard Deviation NA SD was not calculable as only 1 participant was evaluable at this time point.	-6.4 beats per minute Standard Deviation 2.19
Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 21 (n=0, 1)	NA beats per minute Standard Deviation NA Data was not analyzed as there was no participant evaluable for this arm group at the specified time point.	2.0 beats per minute Standard Deviation NA SD was not calculable as only 1 participant was evaluable at this time point.
Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 28 (n=1, 2)	-2.0 beats per minute Standard Deviation NA SD was not calculable as only 1 participant was evaluable at this time point.	2.0 beats per minute Standard Deviation 8.49
Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 42 (n=4, 2)	3.3 beats per minute Standard Deviation 7.37	-3.0 beats per minute Standard Deviation 4.24
Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 56 (n=0, 3)	NA beats per minute Standard Deviation NA Data was not analyzed as there was no participant evaluable for this arm group at the specified time point.	7.7 beats per minute Standard Deviation 3.21
Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 84 (n=27, 17)	0.8 beats per minute Standard Deviation 9.41	5.1 beats per minute Standard Deviation 14.19
Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91 Change at Day 91 (n=3, 3)	1.0 beats per minute Standard Deviation 9.54	-2.0 beats per minute Standard Deviation 7.21

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 12

Population: Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.

Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.

Outcome measures

Measure	Placebo and Celecoxib n=34 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=35 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Number of Participants With Abnormal Electrocardiogram (ECG) Maximum QTc Interval (msec)	0 participants	7 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Maximum QTcB Interval (Bazett's Correction)	3 participants	9 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Maximum QTcF Interval (Fridericia's Correction)	0 participants	2 participants
Number of Participants With Abnormal Electrocardiogram (ECG) QTcF interval 30 to <60 msec Increase	1 participants	2 participants
Number of Participants With Abnormal Electrocardiogram (ECG) QTcF interval >=60 msec Increase	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12

Population: Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Detailed categorical data was not estimated since summarized continuous data of the vital signs were considered sufficient for the analysis as per investigator's discretion.

Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 12 was reported.

Outcome measures

Measure	Placebo and Celecoxib n=35 Participants Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 Participants CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Number of Participants With Categorical Vital Signs Data SBP: >=30 mmHg Increase	1 participants	1 participants
Number of Participants With Categorical Vital Signs Data DBP: >=30 mmHg Increase	1 participants	3 participants

Adverse Events

Placebo and Celecoxib

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

CP-195543 and Celecoxib

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo and Celecoxib n=35 participants at risk Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 participants at risk CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Cardiac disorders Coronary artery disease	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Bronchitis	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Gastroenteritis viral	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Metabolism and nutrition disorders Dehydration	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Renal and urinary disorders Renal failure acute	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.

Other adverse events

Measure	Placebo and Celecoxib n=35 participants at risk Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\>=) 10 milligram per week (mg/week) and less than or equal to (\<=) 25 mg/week via oral or parenteral route was continued as background therapy.	CP-195543 and Celecoxib n=34 participants at risk CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \>=10 mg/week and \<=25 mg/week via oral or parenteral route was continued as background therapy.
Gastrointestinal disorders Rectal polyp	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Eye disorders Eyelid oedema	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Abdominal distension	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Abdominal pain	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Abdominal pain lower	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Colitis	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Constipation	5.7% 2/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Dental caries	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Diarrhoea	14.3% 5/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	50.0% 17/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Dry mouth	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	5.9% 2/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Dyspepsia	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	14.7% 5/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Dysphagia	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Gastrooesophageal reflux disease	8.6% 3/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	11.8% 4/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Haematochezia	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Melaena	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Nausea	11.4% 4/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	11.8% 4/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Gastrointestinal disorders Vomiting	5.7% 2/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	8.8% 3/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
General disorders Chills	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
General disorders Cyst	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
General disorders Oedema peripheral	5.7% 2/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
General disorders Pain	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
General disorders Pyrexia	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Bronchitis	5.7% 2/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Candidiasis	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Ear infection	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Furuncle	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Influenza	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Nasopharyngitis	11.4% 4/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Otitis media	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Sinusitis	5.7% 2/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Tooth abscess	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Upper respiratory tract infection	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Urinary tract infection	5.7% 2/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Injury, poisoning and procedural complications Contusion	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Injury, poisoning and procedural complications Joint injury	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Investigations Blood creatinine increased	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Investigations Weight increased	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Metabolism and nutrition disorders Hyperlipidaemia	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Musculoskeletal and connective tissue disorders Joint swelling	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Musculoskeletal and connective tissue disorders Nodule on extremity	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Musculoskeletal and connective tissue disorders Pain in jaw	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Nervous system disorders Dizziness	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Nervous system disorders Headache	17.1% 6/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	8.8% 3/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Nervous system disorders Paraesthesia	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Psychiatric disorders Anxiety	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Renal and urinary disorders Chromaturia	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Reproductive system and breast disorders Breast mass	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Respiratory, thoracic and mediastinal disorders Cough	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	5.9% 2/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Respiratory, thoracic and mediastinal disorders Sinus congestion	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Skin and subcutaneous tissue disorders Blister	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Skin and subcutaneous tissue disorders Erythema	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Skin and subcutaneous tissue disorders Rash	0.00% 0/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	5.9% 2/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Skin and subcutaneous tissue disorders Swelling face	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.
Vascular disorders Hypertension	2.9% 1/35 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER